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United States Patent |
6,254,614
|
Jesseph
|
July 3, 2001
|
Device and method for improved diagnosis and treatment of cancer
Abstract
A device, in several configurations, which fixes a breast in distended,
stable position using negative pressure, and minimizes or halts lymphatic
flow from the breast. The invention allows for improvement in imaging and
intervention in diagnosis and treatment of early stage human breast
cancer. An image-guided system which allows accurate and bloodless access
to breast tissue; guided by MRI or CT; using a unique saw and cautery
device; in linear and rotary configurations to remove small or large
lesions from the breast.
Inventors:
|
Jesseph; Jerry M. (2131 Meadow Bluff Ct., Bloomington, IN 47401)
|
Appl. No.:
|
419538 |
Filed:
|
October 18, 1999 |
Current U.S. Class: |
606/130; 600/562; 601/14 |
Intern'l Class: |
A61B 010/00; A61H 009/00 |
Field of Search: |
600/562,565,235
606/130,201
601/14
|
References Cited
U.S. Patent Documents
532236 | Jan., 1895 | Hardesty | 601/14.
|
667447 | Feb., 1901 | Miller | 601/14.
|
936434 | Oct., 1909 | Eganhouse | 601/14.
|
1222494 | Apr., 1917 | Thomas | 601/14.
|
3382867 | May., 1968 | Reaves | 601/7.
|
3785369 | Jan., 1974 | Tallent | 601/14.
|
3828766 | Aug., 1974 | Krasnow | 600/391.
|
3913569 | Oct., 1975 | Kanonas | 601/14.
|
4029088 | Jun., 1977 | Wu | 601/14.
|
4111192 | Sep., 1978 | Wu | 601/14.
|
5415620 | May., 1995 | Chen | 601/14.
|
5499989 | Mar., 1996 | LaBash | 606/130.
|
5520613 | May., 1996 | Copelan | 601/14.
|
5678549 | Oct., 1997 | Heywand-Koebrunner et al. | 128/653.
|
5702405 | Dec., 1997 | Heywang-Koebrunner | 606/130.
|
5807255 | Sep., 1998 | Yokota et al. | 600/415.
|
5913863 | Jun., 1999 | Fischer et al. | 606/130.
|
5971998 | Oct., 1999 | Russell et al. | 606/130.
|
6010466 | Jan., 2000 | McGeorge | 601/14.
|
Foreign Patent Documents |
2191700 | Dec., 1987 | GB | 601/14.
|
Primary Examiner: Mancene; Gene
Assistant Examiner: Priddy; Michael B.
Attorney, Agent or Firm: Woodard, Emhardt, Naughton, Moriarty & McNett
Claims
What is claimed is:
1. A fixation apparatus for a breast comprising:
a cup-like body, the body having a side wall with an open top end and an
open bottom end and a fluid evacuation duct, the body defining a chamber
adapted to receive therein at least a portion of the breast;
a gasket attached to the bottom end, the gasket adapted to provide a
substantially fluid tight seal between the body and a first area of skin
around the breast; and,
a suction ring attached to the top end, the ring adapted to provide a
substantially fluid tight seal between the body and a second area on the
breast.
2. The fixation apparatus of claim 1, further comprising a hose attached to
the fluid evacuation duct, the hose connecting the body to a pump capable
of evacuating fluid in the cup-like body when the body is mounted on the
breast such that the gasket and the suction ring provide a substantially
fluid tight seal between the body and the first and the second areas
respectively.
3. The fixation apparatus of claim 1, wherein the cup-like body is
frustospherical in shape.
4. The fixation apparatus of claim 1, wherein the cup-like body is funnel
shaped.
5. The fixation apparatus of claim 1, wherein the fixation apparatus is
manufactured of materials which are transparent to MRI.
6. The fixation apparatus of claim 1, further including an adhesive to
attach the gasket to the first area and to attach the suction ring to the
second area.
7. The fixation apparatus of claim 2, further including a pressure gauge to
monitor the pressure within the cup-like body.
8. The fixation apparatus of claim 1, further including an interventional
device and an imaging device and an adjustable stage, wherein the suction
ring is mounted on the adjustable stage, the adjustable stage securing the
interventional device in an alignment, the imaging device for guiding the
alignment of the interventional device.
9. The fixation apparatus of claim 1, wherein the suction ring is mounted
on an adjustable stage.
10. The fixation apparatus of claim 9, further including an interventional
device, the interventional device held in an alignment by the adjustable
stage, the alignment permitting precise excision of a specimen of tissue
from the breast.
11. The fixation apparatus of claim 10, further including an imaging
device, the imaging device for guiding the alignment of the interventional
device.
12. The fixation apparatus of claim 10, wherein the interventional device
is a biopsy device.
13. The fixation apparatus of claim 9, wherein the adjustable stage has a
first portion with a first end and a second end and a second portion, the
second portion of the adjustable stage being generally ring shaped, the
second end of the first portion being connected to the second portion.
14. The apparatus of claim 1, wherein the body is MRI transparent.
15. The apparatus of claim 1, further including an imaging device
associated with the body for imaging the breast.
16. The apparatus of claim 15, wherein the imaging device is an MRI device.
17. The apparatus of claim 15, wherein the imaging device is an ultrasound
device.
18. The apparatus of claim 15, wherein the imaging device is a CT device.
19. The apparatus of claim 15, wherein at least a portion of the imaging
device is positioned within the chamber.
20. The apparatus of claim 1, further including an interventional device
associated with the body for treating the breast.
21. The apparatus of claim 1, wherein the first area of skin includes skin
on the breast.
22. The apparatus of claim 1, wherein the first area of skin includes skin
adjacent the breast.
23. A fixation apparatus for an anatomical protuberance comprising:
a cup-like body having a continuous wall and a port, the wall being open at
one end, the wall defining a volume adapted to receive therein the
protuberance without the protuberance contacting the wall;
a gasket attached to the end, the gasket adapted to provide a substantially
fluid tight seal between the body and an area of skin around the
protuberance; and
wherein the body is MRI transparent.
24. The fixation apparatus of claim 23, further comprising a tubular member
connecting the port to a pump, the pump for removing fluid from the volume
to create a reduced or negative pressure within the volume and a pressure
gauge connected to the fixation apparatus to monitor the pressure within
the cup-like body.
25. The fixation apparatus of claim 23, wherein the cup-like body is
generally hemispherical in shape.
26. The fixation apparatus of claim 23, wherein the cup-like body is funnel
shaped.
27. The fixation apparatus of claim 23, wherein the gasket is attached to
the area of skin using an adhesive.
28. The apparatus of claim 23, further including an imaging device
associated with the body for treating the protuberance.
29. The apparatus of claim 23, wherein the wall includes an opening, the
apparatus further including a suction ring attached to the opening, the
ring adapted to provide a substantially fluid tight seal between the
housing and a second area of skin around the protuberance.
30. The apparatus of claim 29, further including an interventional device
associated with the body for treating the protuberance.
31. The apparatus of claim 29, wherein the suction ring is mounted on an
adjustable stage.
32. The apparatus of claim 23, further including an interventional device
associated with the body for treating the protuberance, the interventional
device capable of being introduced through the port.
Description
BACKGROUND OF THE INVENTION
For more than a century, it has been understood that breast cancers spread
from the breast primarily by entering into and passing along lymphatic
channels draining the breast. These channels pass into the armpit, into
the skin and through the chest wall. Tumor spread is partly impeded by the
presence of lymph nodes; in which tumor cells can remain and grow, or pass
though and into the blood stream. Near the turn of the century, William
Halsted proved the utility of this knowledge by surgically removing all
possible lymphatic channels in addition to removing the breast. While this
had the disadvantage of being a fairly mutilating procedure, he was able
to reduce the rate of local recurrence of breast cancer to six percent
from the previously reported recurrence rate of fifty to eighty-five
percent when only the breast was removed.
Since the time of Halsted, surgical approaches have moved away from radical
techniques toward tissue-sparing approaches. With the ability of earlier
detection, minimal surgery; coupled with radiation and/or chemotherapy,
has achieved similar results in preventing local recurrence. The problem
of detection of tumor spread remains. Often, women who appear to have
early stage disease will die of metastatic cancer despite a lack of
evidence of spread. Therefore, breast cancer has been called a "systemic
disease." This is most likely because cancer cells can spread undetected
through lymphatic pathways; often early in the disease.
The primary determinant of survival in breast cancer is the presence or
absence of tumor cells within the axillary (armpit) lymph nodes. Axillary
nodes are removed to detect tumor spread and prevent recurrence. Tumor
spread into other lymphatics that drain the breast is still undetectable,
and probably accounts for cases of metastasis when the axillary lymph
nodes are free of cancer. Lymphatic flow is determined by pressure and
osmolar gradients. Increases in interstitial fluid or in externally
applied pressure will enhance lymphatic flow. Entry of tumor cells into
lymphatics is an active process of the tumor cells. Once in the lymphatic
channels, tumor cells are carried along passively by the flow of lymphatic
fluid. Any increase in interstitial fluid or pressure will, therefore,
increase the rate of tumor spread.
Breast cancer can recur many years after initial treatment. Presumably,
this is because of the undetectable spread of small numbers of tumor
cells. While it has been known for many years that cutting into tumors can
enhance their spread, present techniques of needle and core biopsies do
just this. It has been claimed that these maneuvers don't spread cancer;
however, the truth of these claims might not be apparent for many years.
Presently, the modalities of palpation, x-ray, ultrasound, and MRI are used
to detect human breast cancers. Some of these techniques are used also for
image-guided biopsy of breast tissue. Mammography is the mainstay of
current early detection of breast cancer. This technique requires the
forceful compression of the breast between plates to achieve acceptable
images. Other known detection techniques, as previously mentioned, include
ultrasound, magnetic resonance imaging (hereinafter "MRI"), and
computerized tomography (hereinafter "CT"). Ultrasound images of the
breast are obtained using a probe placed directly against the skin of the
breast. MRI images are made by placing the breast in a magnetic field,
between coils or hanging into a well that is surrounded by a coil. The
principles of MRI are known to those of ordinary skill in the art. A
description may be found in U.S. Pat. No. 5,437,280 to Hussman entitled
"Magnetic Resonance Breast Localizer" which is hereby incorporated by
reference in its entirety. Stereotactic biopsy techniques are done in a
similar fashion; with a patient lying prone, with the breast hanging
through a hole in the table. All these methods have shortcomings related
to the flaccid nature of the breast which leads to difficulty in
manipulating and orienting the organ. Additionally, some of these methods
are very uncomfortable for the patient. The pain often associated with the
forceful compression of the breast between plates in mammography being a
prime example.
Early detection of breast cancers has spurred increasing interest in early
intervention. Open biopsy techniques have given way to more image-guided
biopsy methods which currently require forceful compression of the breast
for stabilization, and require the forceful passage of instruments into
the breast which often cause considerable bleeding; especially once the
compression has been released. The tissue is in a distorted state and
accurate removal of a specific volume of breast tissue is difficult.
Present techniques for image-guided biopsy of the breast are limited by
the size of the lesion to be removed, and by continuing challenges of
bleeding and spread of tumor cells. Removal of lesions greater than a
centimeter is generally not possible by these methods.
One object of the present invention is to allow for improved imaging and
intervention in diagnosis and treatment of cancer, particularly early
stage human breast cancer. Another object of the present invention is to
allow for the accurate removal of tissue in a minimally bleeding or
bloodless field.
SUMMARY OF THE INVENTION
One embodiment of the invention is a fixation apparatus for a breast
comprising a cup-like body having a side wall with an open top end and an
open bottom end and a fluid evacuation duct. The body defines a chamber
adapted to receive a portion of the breast. A gasket is attached to the
bottom end and is adapted to provide a substantially fluid tight seal
between the body and an area of skin around the breast. A suction ring is
attached to the top end and is adapted to provide a substantially fluid
tight seal between the body and a second area on the breast. The apparatus
may further include a hose attached to the fluid evacuation duct and
connected to a pump capable of evacuating fluid in the cup-like body and
mounted on the breast such that the gasket and suction ring provide a
substantially fluid tight seal between the body and the first and second
areas.
Another embodiment of the present invention is also a fixation apparatus
for a protuberance of a body that comprises a cup-like body having a
continuous wall and a port. The wall is open at one end and the wall
defines a volume adapted to receive the protuberance without the
protuberance contacting the wall. A gasket is attached to and adapted to
provide a substantially fluid tight seal between the body and an area of
skin around the protuberance. The fixation apparatus may further include a
tubular member connecting the port to a pump for removing fluid to create
a reduced or negative pressure within the volume and a pressure gauge
connected to the fixation apparatus to monitor the pressure in the
cup-like body.
Another embodiment of the present invention is a minimally invasive tissue
saw. The tissue saw comprises a shaft extending along a first axis between
a proximal end and a distal end and has a first cross section at the
distal end. The tissue saw has a cutting head extending between a
connecting end and a cutting end. The connecting end is pivotally
connected to the distal end of the shaft so that at least a portion of the
cutting head is able to swivel back and forth substantially along a second
axis, the second axis in a direction transverse to the first axis. The
cutting head has a cutting surface at the cutting end and extends across a
width in the second axis and is able to swivel back and forth to cut a
slit in tissue. The slit has a second cross section with the cutting head
having at least one insertion surface substantially adjacent the cutting
surface. The insertion surface extends between the connecting end and the
cutting end and tapers from the first cross section at the connecting end
to the second cross section at the cutting end. A portion of the insertion
surface is a cauterizing element and extends around a strip of the
insertion surface for cauterizing the tissue surrounding the slit.
In yet another embodiment the present invention is a minimally invasive
device for removing a specimen of tissue with a cylinder extending along
and rotatable around a first axis defined between a proximal end and a
distal end. The cylinder has an interior surface and an exterior surface
with a plurality of cutting arms. Each arm has an inner surface and an
outer surface with the surfaces extending between a forward edge and a
trailing edge. A portion of the forward edge defines a cutting edge and
the cutting edge extends past the distal end of the cylinder to cut
tissue. The arms are pivotally connected to the cylinder at the distal end
and pivot between an open position and a closed position. The inner
surface of each arm is adjacent to and substantially overlaps the exterior
surface of the cylinder in the open position. A portion of the inner
surface of each arm extends beyond the distal end of the cylinder and is
adjacent tissue in the closed position.
Another embodiment of the invention is a minimally invasive tissue biopsy
device comprising a cannula having a proximal end and a distal end and a
first longitudinal axis defined between the ends. The device also includes
a means for cutting a slit in tissue with the slit being in a second axis
substantially transverse to the first longitudinal axis. The device
further includes a trailing means for cauterizing substantially all of the
tissue surrounding the slit.
Another embodiment of the invention is a method comprising: providing a
retaining sleeve and a tissue saw. The retaining sleeve has a proximal and
a distal end with the retaining sleeve having a first cross-section at the
distal end. The tissue saw has an oscillating cutting head and a trailing
coagulating element. The head has a cutting edge and a tapering insertion
surface for advancing the retaining sleeve and the tissue saw along a
first axis toward a lesion while the cutting edge oscillates back and
forth and cuts an entry wound in tissue. The entry wound is a
substantially linear slit having a second cross-section. The entry wound
is distorted from the second cross-section of the slit to the first
cross-section of the retaining sleeve. The tissue surrounding the slit is
cauterized with the trailing coagulating element. The cauterization occurs
as the tissue saw and retaining sleeve are advanced toward the lesion.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates the prior art form of breast fixation using compression
plates.
FIG. 2 is a side view partially in cross-section of an embodiment of the
breast fixation apparatus of the present invention.
FIG. 3 is a partial sectional view of an alternative embodiment of the
breast fixation apparatus of the present invention.
FIG. 4 is a enlarged perspective view of a portion of the embodiment of
FIG. 3.
FIG. 5 illustrates an embodiment of a tissue saw and retaining sleeve being
introduced into an incision in the breast while held by a fixation
apparatus of the present invention.
FIG. 6A illustrates a cross-section of the opening in the tissue cut by an
embodiment of the tissue saw of the present invention.
FIG. 6B shows the transition between the cross-section of the opening cut
into the tissue by a tissue saw of the present invention and the
cross-section of the shaft or retaining sleeve which trails the cutting
surface of the tissue saw.
FIG. 7A is a top cross-sectional view of an embodiment of the tissue saw of
the present invention.
FIG. 7B is a side cross-sectional view of the embodiment of FIG. 7A.
FIG. 8A is an end view of FIG. 7A along the lines 1--1.
FIG. 8B is an end view of the embodiment of FIG. 7A along the lines 2--2.
FIG. 9 is a top cross-sectional view of one example of a driving mechanism
for the tissue saws of the present invention.
FIG. 10 is a perspective view of one embodiment of the coring device of the
present invention.
FIG. 11A is an end view of the coring device of FIG. 10 in the open
position.
FIG. 11B is an end view of the coring device of FIG. 10 in the closed
position.
FIG. 12 is an illustration of the tissue saw being withdrawn through the
retaining sleeve prior to encountering the lesion.
FIG. 13 is an illustration of the coring device of the present invention
being advanced through the retaining sleeve toward the lesion.
FIG. 14 illustrates the path the coring device of one embodiment of the
present invention cuts into the tissue surrounding the lesion to be
excised and the shape of the specimen of tissue cut.
FIG. 15 illustrates the coagulated cavity and coagulated collapsing slit
left behind after the withdrawal of the devices of the present invention.
FIG. 16 is a top view of another embodiment of the tissue saw of the
present invention.
FIG. 17A is a side view of another embodiment of the coring device of the
present invention.
FIG. 17B is an end view of the embodiment of the coring device of FIG. 17A.
FIG. 18A is a side view of the coring device of FIG. 17A in the closed
position.
FIG. 18B is an end view of the embodiment of the coring device of FIG. 17A
in the closed position.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of promoting an understanding of the principles of the
invention, reference will now be made to the embodiment illustrated in the
drawings and specific language will be used to describe the same. It will
nevertheless be understood that no limitation of the scope of the
invention is thereby intended, such alterations and further modifications
in the illustrated device, and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention relates.
All of the above-mentioned methods, such as mammography, ultrasound, MRI,
etc., have shortcomings related to the flaccid nature of the breast which
leads to difficulty in manipulating and orienting the organ. Additionally,
some of these methods are very uncomfortable for the patient. One
particular and well known discomfort is that associated with mammography
as illustrated in FIG. 1. Breast 10 has a nipple 14 surrounded by an
areola 12 which in turn is surrounded by periareolar skin 13. Breast 10
protrudes from chest wall 16 and is shown forcefully compressed between
compression plates 5, 6 which is necessary to achieve acceptable images.
This is in contrast to the situation found in various embodiments of the
present invention.
With reference to FIG. 2, an embodiment of the fixation device of the
present invention in its simplest form is shown. The device comprises a
cup-like body 20 defining a volume 21 containing the breast 10. It should
be understood that the term cup-like body may include a variety of
different shapes. These shapes include, but are not limited to, a
frustospherical, frustoconical, generally hemispherical, funnel shaped,
pyramidal, or even rectangular configurations which the cup-like body 20
may possess so long as it is capable of enclosing at least a portion of
the breast 10. The breast 10 again has an areola 12 and nipple 14. The
breast 10 is attached to the chest wall 16 as shown in FIG. 2. The
cup-like body 20 is attached to the chest wall 16 by means of a flexible
flanged gasket 22. It should be understood that if cup-like body 20 is
appropriately shaped at its bottom end where gasket 22 is shown, the
gasket 22 may instead be omitted and an adhesive applied directly to
cup-like body 20 to attach it to the skin of the chest wall 16 or the
breast 10. When such is the case, medical grade solvents may be applied at
a later time to remove the apparatus.
The cup-like body 20, surrounding the breast 10, can be evacuated to
varying degrees of negative pressure. While the flexible flanged gasket 22
is shown applied to the skin of the chest wall 16 around the breast 10, it
is understood that the gasket 22 may also be attached directly to the skin
of the breast 10 if so desired. The gasket 22 allows a fluid-tight seal to
be formed in the cup-like body 20. Air or other fluids are removed from
the volume 21 containing breast 10 by means of a vacuum pump 24 while a
distending pressure is monitored by a pressure gauge 25. As the cup-like
body 20 is evacuated, the breast 10 is drawn into the cup-like body 20
toward the top surface 27 and away from the chest wall 16.
Since negative pressure is applied to all surfaces of the breast 10 evenly
(as illustrated in FIGS. 2 and 3 with outwardly directed arrows), the
breast 10 will expand to its maximum volume and remain in a fixed position
away from the chest wall 16. In this position, the breast 10 can be placed
in an imaging or interventional device 26. It should be understood that
imaging or interventional device 26 may include, but is not limited to,
devices such as an MRI coil, an ultrasound device, a CT scanner, or a
radiation beam with any of these devices placed around or at a distance
from the breast 10. Since fixation of the breast 10 is not dependent on
gravity, the patient need not lay prone, but instead may be placed in many
different positions for optimal advantage in imaging or irradiation as
well as patient comfort.
With references to FIGS. 3 and 4, another embodiment of the present
invention is shown which facilitates image-guided intervention of the
breast 10. In this embodiment, the cup-like body 30 again has a gasket 32
which together enclose a volume 31. As in the previous embodiment,
cup-like body 30 may take a variety of configurations and shapes. The
volume 31 enclosed includes at least a portion of the breast 10. As
before, the cup-like body 30 may include one or more hoses 33 connected to
a vacuum pump 34. In both embodiments, the cup-like body 20, 30 will have
an evacuation duct or port of some kind to which the flexible tubular
member or hose may be attached to allow for evacuation of air or other
fluids from within the body 20, 30. It is again preferable to attach
cup-like body 30 to the chest wall 16 by means of gasket 32 (with or
without the use of an adhesive as desired).
In this preferred embodiment, however, the periareolar skin 13 is
preferably left exposed. Thus, surgical intervention by a variety of
instrumentation devices, one embodiment of which will be discussed further
below, is possible through the periareolar skin 13. This is accomplished
by providing a suction ring 38 which is applied to the periareolar skin 13
around the areola 12 of the breast 10. When the ring 38 is applied, it
provides access to the periareolar skin 13 of the breast 10 outside the
cup-like body 30, while maintaining negative pressure and fixation of the
breast 10. Again, the distending pressure is preferably monitored by a
pressure gauge 35. While suction ring 38 is shown applied to periareolar
skin 13, it should be understood that a variety of sizes and locations for
suction ring 38 are contemplated as within the scope of the invention. For
example, suction ring 38 might be oval in configuration and not centered
directly on the areola 12 thus exposing skin of breast 10 adjacent to the
periareolar skin 13 if such is preferred for easier access during surgical
intervention. Similarly, ring 38 might be larger in diameter and placed
lower down on the breast 10 exposing more skin for easier access as
required. It should also be understood that such variations in size and
configuration are equally applicable to gasket 32. Thus, gasket 32 may be
placed to create a substantially fluid tight seal between both the skin of
the breast 10 as well as the skin of the chest wall 16 as desired.
The suction ring 38 is mounted on a adjustable stage 40 that can be
adjusted for varying sizes of breast 10. The adjustable stage 40 acts as a
platform for a variety of image-guided devices. It should be understood
that a variety of other platforms are contemplated as within the scope of
the invention that may contain alternative translational and/or rotational
mechanisms for image-guided interventional devices. By way of small
incisions, in or around the areola 12 and periareolar skin 13, various
instruments and biopsy devices can be placed into the breast: guided by
images from x-ray, ultrasound, MRI, or CT.
With reference to FIGS. 3 and 4, it is seen that one such adjustable stage
40 includes the ability for a 360 degree circumferential adjustment as
indicated by the arrow 44 as well as an extensible holder which allows for
adjustment in the azimuth direction as indicated by the arrow 42. In its
simplest form, the adjustable stage 40 has a first portion 41 and a second
portion 43. The first portion 41 may be extended or retracted for
adjustment in the azimuth direction and terminates in a first end 45 in
which a variety of image-guided devices may be attached. The second end 46
of first portion 41 is connected to the second portion 43 of adjustable
stage 40. The second portion 43 of adjustable stage 40 is generally ring
shaped and first portion 41 may be rotated about the circumference of
second portion 43 and locked into position as desired. Similarly, the
amount of extension of first portion 41 is also adjustable.
It is contemplated as within the scope of the invention that the suction
chamber defined by cup like body 20, 30 can be of various sizes to
accommodate equipment, coils, stages and the like. It should be understood
that the chamber may detach from the imaging or interventional devices or
both so that the breast could maintain a static position in space, as when
being placed, first, in an imaging device and then into a targeting biopsy
device. It should be further understood that the unique aspect of the
present invention is the ability to stabilize the breast or other bodily
protuberance in a position in space and that a wide variety of
configurations of the chamber are contemplated as within the scope of the
invention for achieving this end.
In one preferred embodiment the patient is lying prone and slightly tilted,
bringing the breast into position with the suction chamber defined by the
cup-like body. Then the imaging device may be arranged to be inside or
outside the chamber, depending upon its particular requirements
(e.g.--"surface coils" for MRI). As disclosed above, in one embodiment a
secondary suction ring maintains exposure of the areola for entry using a
variety of interventional devices, in particular biopsy devices. The
secondary suction ring, being placed on an adjustable stage, aids in
permitting a wide variety of configurations in arranging the chamber,
imaging device, and interventional device as appropriate for particular
surgical applications.
As shown in FIGS. 3 and 4, after the cup-like body 30 is evacuated, and the
breast 10 fixed, imaging devices 36 may be used to locate precisely lesion
47 and then an interventional device shown as a line 48 in FIGS. 3 and 4
is inserted into the breast to precisely locate and excise the cancerous
cells or tumor forming the lesion 47. A wide variety of interventional
devices are contemplated for use in place of line 48 in FIGS. 3 and 4.
Such devices may include, but are not limited to, those biopsy devices
disclosed in U.S. Pat. Nos. 5,111,828, 5,197,484, and 5,353,804 all to
Kornberg et al. as well as U.S. Pat. No. 5,795,308 to Russin and U.S. Pat.
No. 5,817,034 to Milliman et al. all of which are hereby incorporated by
reference. The preferred interventional devices, however, will be
disclosed below as yet another embodiment of the present invention.
Thus, by way of small incisions, in or around the areola 12, various
instruments and biopsy devices (guided by images from such things as
x-ray, ultrasound, MRI, or CT) may be used to precisely treat the lesion
47 (or lesions) in the breast 10 which has been fixed in space. As is
known by those of ordinary skill in the art, anatomically the breast is
arranged radially in duct-lobule units spreading out from the
nipple-areolar complex. (See pages 20-21 of The Breast Cancer Survival
Manual by John Link, M.D., published by Henry Holt and Company, Inc.,
1998, these pages are herein incorporated by reference). The fixation
device of the present invention allows directed intervention along radial
anatomic compartments, and consequently, allows more precise anatomic
alignment for diagnostic and therapeutic intervention. It is seen that the
various embodiments described above of the present invention may be used
to fix the breast in a distended, stable position using negative pressure.
The stable fixation of the breast in space is advantageous for breast
imaging, tissue biopsy and specific local therapy.
Additional utility of the present invention derives from its ability to
temporarily minimize or halt lymphatic flow from the breast and, thereby,
halt the spread of tumor cells via the lymphatics. This is in contrast to
present techniques which generally involve the forceful (and potentially
painful) compression of the breast between two plates. This externally
applied pressure enhances lymphatic flow (thus having the potential to
increase the rate at which tumor cells spread) as opposed to minimizing or
halting it. It is understood by those of ordinary skill in the art that
cancerous cells are less dangerous if they remain intraductal. If a cancer
becomes invasive or interductal, there is greater opportunity for the
cancerous cells to spread. Every time a breast is compressed to the extent
necessary to perform mammography, pressure in the system is increased.
Increasing the pressure in the system increases the likelihood that the
cancerous cells will either (1) be forced through the walls of the ductal
tissue; and/or (2) increase the rate of lymphatic flow so that the cancer
cells will filter through the labyrinth of the lymph nodes and the
lymphatic system allowing the disease to spread to other portions of the
body and progress to the systemic stage from localized. Thus, in addition
to deriving utility from minimizing or halting lymphatic flow, the
fixation device of the present invention is advantageous simply because it
does not increase the pressure on the system, as is the case with many
conventional techniques. The invention has further utility in applications
such as those involving external beam radiation treatment. Both of the
above disclosed embodiments for a breast fixator draw the breast 10 away
from the chest wall 16 into a position more favorable to safe and specific
treatment. It should be understood that the dimensions and materials of
the above described embodiments can and will vary widely depending on the
particular needs of the imaging or treatment modality. It should be
further understood that the dimensions and materials of the device may
also vary based on the size of the organ of the patient being treated.
Other advantages of the fixation device of the present invention are
numerous. For example, a breast fixator provides the ability to stabilize
the breast in space, both for imaging and for intervention. A fixation
device as disclosed in the present application has particularly
advantageous features for use with MRI. With the breast fixed in space,
different modalities can be applied and the patient can be moved from
place to place. For example, MRI imaging takes some time, and keeping a
patient in the scanner while doing a procedure wastes time for other
imaging. However, by using a fixator to stabilize the breast as in the
present invention, the breast can be imaged and the data/set of
information about the breast can be stored and regenerated and
manipulated. Once the data set is fixed, and the points on the fixator are
referenced, the breast can be manipulated in a different place with
different and cheaper localizing devices. In one preferred embodiment, the
breast is fixed within a fixator which itself has coordinate markings. The
breast is then imaged along with the coordinating marks. The patient is
then removed to an interventional area where, using ultrasound guidance
within the superimposed data sets of ultrasound and MRI, the areas to
undergo surgical intervention can be targeted. It is even possible to
integrate MRI, ultrasound, and CT images of the breast and use all that
information simultaneously. It should be understood that variations of the
above described method of use of the breast fixation of the present
application that would be known to those of ordinary skill in the art, are
contemplated as within the scope of the invention. In particular, a
variety of different imaging devices in connection with the interventional
devices discussed above as well as the preferred embodiment discussed
below are contemplated as within the scope of the invention.
With reference to FIGS. 5-18, there are illustrated various embodiments of
a tissue saw and coring device for use in a minimally invasive procedure
in a minimally bleeding or bloodless field and for removing a specimen of
tissue. The specimen of tissue to be removed is that surrounding and
including a lesion 80 found using the early detection methods of present
technology. As previously indicated, the various embodiments of the tissue
saw and coring devices disclosed below are intended to be used in
conjunction with the breast fixation device of the present invention. It
should be understood, however, that the devices and methods disclosed
below may be used independently of the fixation device described above. It
should be further understood that the tissue saw and coring devices
discussed below will find utility with a wide variety of imaging devices
including MRI. One preferred embodiment for use with MRI imaging
modalities is if the tissue saw and/or the coring device, as well as any
retaining sleeve used, are made of MR transparent materials. These MR
transparent materials may include titanium, plastic (polycarbonate), and
other materials known to those of ordinary skill in the art.
With respect to FIGS. 5-9, there is illustrated one embodiment of a
minimally invasive tissue saw 101 for permitting access to a lesion 80 in
a minimally bleeding or bloodless field. The tissue saw 101 is preferably
first inserted through retaining sleeve 103. The retaining sleeve 103 may
be held, for example, by the previously disclosed movable stage 40 (not
shown) in the first portion 41 at the first end 45. The movable stage 40
(not shown) is aligned so that the tissue saw 101 lines up with an
incision 90 in periareolar skin 13 and/or adjacent areola 12 and nipple
14. In its simplest form, the tissue saw 101 comprises a shaft 105 with an
attached cutting head 110. The shaft 105 may be either a generally hollow
cylinder or a solid rod (with passages as necessary for cables or other
means for swiveling the cutting head 110) extending through the retaining
sleeve 103. The retaining sleeve 103 is essentially a cylinder or cannula.
A wide variety of shapes and forms other than the generally circular form
shown for both the shaft 105 and retaining sleeve 103 are contemplated as
within the scope of the invention.
Shaft 105 has a proximal end 106 and a distal end 107. Shaft 105 has a
first cross-section 109 at distal end 107. The cutting head 110 has a
connecting end 112 and a cutting end 114. The connecting end 112 of
cutting head 110 is attached to the distal end 107 of shaft 105. As
illustrated in FIGS. 5 and 6, the shaft 105 has a first cross-section 109
that is generally circular with a diameter 109a. The shaft 105 extends
between the proximal end 106 and distal end 107 along a first longitudinal
axis 108. The tissue saw 101 is intended to cut a slit 122. Slit 122 is
cut by the cutting surface 120 of cutting head 110. Cutting surface 120 is
shown with serrations 121. It should be understood that the use of
serrations 121 at the cutting end of cutting surface 120, while preferred,
is not necessary for operation of the present invention. Slit 122 is a
long narrow aperture of minimal thickness having a width 125. Width 125 is
defined in a plane of the second axis 116 which cutting head 110 creates
by swiveling back and forth of cutting surface 120 in the direction of the
arrows 124 (see FIGS. 5 and 7A).
While cutting surface 120 is illustrated as having serrations 121, it
should be understood that alternative embodiments wherein the cutting
surface is a generally smooth blade are contemplated as within the scope
of the invention. In one embodiment, cutting surface 120 is an arc of a
circle and has a width 125 (in the second axis 116 transverse to the first
axis 108) equal to the diameter of either shaft 105 or retaining sleeve
103. It should be understood, however, that a variety of configurations
and widths for cutting surface 120 are contemplated as within the scope of
the invention. For example, cutting surface 120 may be an arc of a circle,
a straight blade, polygonal, or some combination of the foregoing as known
to those of ordinary skill in the art. It should be further understood
that the cutting surface 120 may be a portion of the continuous perimeter
of a generally circular bandsaw. This bandsaw may possess a wide variety
of shapes and sizes. For example, the bandsaw may have a diameter at least
equal to .pi./2 times the diameter of the shaft 105 or retaining sleeve
103 in which case no pivoting of the bandsaw would be necessary to cut a
slit sufficiently large to encompass the retaining sleeve 103 or shaft
105. In an embodiment where the bandsaw had a diameter at least equal to
.pi./2 times the diameter of shaft 105, the shaft 105 could be a generally
hollow cylinder and the bandsaw could be detachable from the distal end
107 of the shaft 105, the bandsaw being collapsible so that it could be
retracted through the shaft 105 and/or the retaining sleeve 103 as
necessary. It is also contemplated as within the scope of the invention
that a bandsaw might be used with a diameter equal to the diameter of the
shaft 105 or retaining sleeve 103. In this embodiment, the bandsaw would
need to pivot from side to side as discussed further below. The bandsaw
could be rotated by various driving mechanisms known to those of ordinary
skill in the art. One driving mechanism for a circular bandsaw would be an
electric motor rotating in a continuous loop driving the circular bandsaw.
Cutting head 110 has an insertion surface 130 which provides a transition
from the first cross-section 109 of shaft 105 to the second cross-section
123 of the slit 122. In the embodiments illustrated in the figures of the
present application, insertion surface 130 is generally shown as
comprising a first upper surface 132 having a first cauterizing plate or
element 133 and a second lower surface 134 having a second cauterizing
plate or element 135. It should be understood, however, that insertion
surface 130 may be an integral whole extending around the entirety of the
cutting head 110 and transitioning between first cross-section 109 and
second cross-section 123. It should also be understood that instead of two
surfaces 132 and 134, the insertion surface 130 may instead be made up of
a plurality of surfaces as opposed to merely two. The transition between
the first cross-sectional shape 109 of the shaft 105 and the second
cross-sectional shape 123 of the substantially linear slit 122 may take a
variety of configurations.
While upper surface 132 and lower surface 134 are shown as a straight line
taper from the cutting surface 120 to the distal end 107 of shaft 105, it
should be understood that a variety of profiles for the transition from
the first cross section 109 of shaft 105 to the second cross section 123
of slit 122 are contemplated as within the scope of the invention. For
example, upper surface 132 and lower surface 134 may be a series of steps,
or a graduated transition that is concave or convex in shape or some
combination of these and other configurations known to those of ordinary
skill in the art. In either case, the upper surface 132 and lower surface
134 act to spread the tissue sliced by cutting surface 120 from the
substantially linear slit 122 having second cross-sectional shape 123 into
a shape corresponding to the first cross-sectional shape of shaft 105 or
retaining sleeve 103.
The cutting head 110 is preferably pivotally connected to the distal end
107 of shaft 105. In one embodiment, the entire cutting head 110 will
pivot. In other embodiments, however, only a portion of the cutting head
110 will be pivotally connected, such as the cutting surface 120. It
should be understood that the term pivotally connected encompasses those
situations in which cutting surface 120 slides along a track or other
guide path located in between first upper surface 132 and second lower
surface 134. In such an embodiment, the cutting surface 120 will pivot
from side to side generally along the second axis 116. It should be
understood by those of ordinary skill in the art that the width 125 of
slit 122 is preferably, but not necessarily, at least a minimum distance
to gain maximum benefit of the improvements of the present invention.
Namely, basic geometric principles (see FIG. 6B) reveal that the
circumference of the shaft 105 should be approximately equal to twice the
width 125 of the slit 122. Thus, to introduce the retaining sleeve 103 up
to the point of the lesion in a minimally bleeding or bloodless
environment, a cutting surface 120 of cutting head 110 with a width 125
equal to the diameter of retaining sleeve 103 should have the ability to
pivot to each side a distance of (.pi./4-0.5) times the diameter of the
retaining sleeve 103 to be introduced into the body.
As previously mentioned, either the cutting head 110 in its entirety may
swivel back and forth, or merely the cutting surface 120. In either
situation, a variety of mechanisms are contemplated as within the scope of
the invention for inducing the cutting surface 120 or cutting head 110 to
swivel back and forth the necessary amount. For example, with reference to
FIG. 7A and 8B, there is illustrated one driving mechanism for the swivel
action of cutting head 110. In this embodiment, cables 140a and 140b
running through cable shafts 142a and 142b are used to cause the necessary
swiveling action. With respect to FIG. 9, there is shown a potential
driving mechanism for the cables 140a and 140b running through cable
shafts 142a and 142b. In this case, the driving mechanism utilizes a
spring block 144 and a cutting trigger 146 intended to be moved back and
forth along an axis as indicated by the arrows 147a and 147b.
It should be understood that an essential element of the tissue saw is the
use of a cauterizing plate or element. The cauterizing plate or element
may be placed on the cutting head 110, preferably, but not necessarily,
adjacent the cutting surface 120. Thus, as the tissue saw 101 is advanced
along the first axis 108, the tissue is first severed by the cutting
surface 120 and then quickly cauterized by, for example, first cauterizing
plate or element 133 and second cauterizing plate or element 135 so as to
provide a minimally bleeding or bloodless field. This aids in preventing
the spread of any tumor cells that might otherwise be released to flow
elsewhere in the body by the cutting of the tissue, in particular the
tissue surrounding or near a lesion 80. The cauterizing elements 133 and
135 both destroy any tumor cells encountered as well as causing
coagulation in the tissue surrounding the slit 122.
The cauterizing elements 133, 135 may act to cauterize in a variety of
manners including being an electrically resistive material so that they
may act as an electric cauterizer, or as a conduit for fiber optic cables
for laser coagulation and other mechanisms known to those of ordinary
skill in the art. It should be understood that alternative locations for
the cauterizing plate or elements are contemplated as within the scope of
the invention. For example, while the cauterizing plate or elements 133,
135 may be located either adjacent cutting surface 120 or elsewhere on the
cutting head 110, it should be understood that the strip of material
acting as a cauterizing element may be placed in a variety of locations.
For example, the cauterizing element could be a continuous strip of
material placed around the circumference of the distal end 107 of shaft
105 or might even be placed around the circumference of a distal end of
the retaining sleeve 103. It should be further understood in some
situations the shaft 105 will be a hollow cylinder and may also be acting
as the retaining sleeve 103. In any case, the essential element of the
tissue saw is that the cutting surface be followed by a trailing
coagulating plate or strip of material which acts to cauterize the tissue
surrounding the opening cut into the body by the cutting surface 120. It
should also be understood that the first cauterizing element 133 and
second cauterizing element 135 in the embodiment illustrated in the
figures as well as discussed in the preceding text, may be either affixed
to the insertion surface 130 or first surface 132 and second surface 134
(or the exterior of the shaft 105 or retaining sleeve 103 as may be the
case) in a variety of manners known to those of ordinary skill in the art
such as adhesives, welding, or being bolted on. Alternatively, it should
also be understood that the cauterizing elements may be integrally formed
upon whatever surface or surfaces are selected for their location.
With respect to FIGS. 10 and 11, one embodiment of the coring device for
removing the specimen of tissue containing the suspected lesion 80 is
illustrated. The device includes a cylinder 160 having a proximal end 161
and a distal end 162. The cylinder 160 extends generally along a first
axis 159, the cylinder 160 rotating around the first axis 159, both to cut
a circumference of a circle in tissue as well as rotating when cutting the
bullet-shaped specimen 81 (see FIG. 14B) free as discussed below. Cylinder
160 has an interior surface 163 and an exterior surface 164. Cylinder 160
is preferably received within retaining sleeve 103 so that the exterior
surface 164 of cylinder 160 is adjacent the interior surface 104a of the
retaining sleeve 103.
It is understood that while it is preferred that the coring device be
inserted up through the interior of the retaining sleeve 103, it is also
possible to use a coring device with a cylinder 160 having a diameter 160a
such that the cylinder 160 may be rotated around the exterior surface 104b
of retaining sleeve 103. This is a less preferred embodiment, however,
since the slit, (e.g., slit 122 with second cross-section 123) while
having been distended by the insertion surfaces (such as first upper
surface 132 and second lower surface 134) to the shape of the shaft 105
and/or the retaining sleeve 103, would require additional cutting and
cauterizing to pass the cylinder 160 around the exterior 104b of retaining
sleeve 103. In contrast, passing cylinder 160 through the interior of
retaining sleeve 103 permits the introduction of the coring head 166 to
the specimen of tissue 81 surrounding the suspected lesion 80 to be
removed without further trauma.
With respect to FIGS. 10 and 11, there are illustrated various details of
coring head 166. In the illustrated embodiment, coring head 166 is shown
with first cutting arm 170 and second cutting arm 180. First cutting arm
170 has an inner surface 171a and an outer surface 171b extending between
first forward edge 172 and first trailing edge 173. At least a portion of
first forward edge 172 comprises a cutting edge 174 which may or may not
be serrated as desired. Additionally, at least a portion of the first
outer surface 171b of first cutting arm 170 acts as a first cauterizing
element 175. The first cauterizing element 175 may be a coagulating plate
or other means known to those of ordinary skill in the art for rapidly
cauterizing the tissue cut by first cutting surface 174. First cutting arm
170 is generally swiveled around a first hinge 178 near first pivoting end
176. Distal from first pivoting end 176 is first far end 177. A first
cable (or rod) 190 may be pulled so that first cutting arm 170 swivels
from its open position (see FIG. 11A) to its closed position for a
completed cut (see FIG. 11B).
In a similar manner, second cutting arm 180 has a second inner surface 181
a and a second outer surface 181b extending between a second forward edge
182 and a second trailing edge 183. Second forward edge 182 has a second
cutting edge 184 along at least a portion of second forward edge 182. It
should be understood that second cutting edge 184, similar to first
cutting edge 174, may or may not be serrated as desired. Also, second
cutting arm 180 has a second cauterizing element 185 which, similar to
first cauterizing element 175, may be attached or integrally formed with
second outer surface 181b. As seen in FIGS. 10 and 11, second cutting arm
180 swivels from an open position to a closed position around a hinge 188
attached nearer to pivoting end 186 than to far end 187. Second cutting
arm 180 is pivoted from its open position to its closed position using a
second cable (or rod) 191 which is preferably attached near the pivoting
end side of the second cutting arm and pulled, or which may instead be
attached near the second far end 187 of second cutting arm 180 and pushed
to force the second cutting arm 180 to swivel from its open position to
its closed position. In the open position, second inner surface 181a is
substantially adjacent the exterior surface 104b of retaining sleeve 103.
In the closed position, the cutting edge 184 and cauterizing element 185
will have cut a bullet shaped specimen 81 (see FIGS. 14A-B) and cauterized
the tissue surrounding the specimen 81 to be removed. It should be
understood that first and second cauterizing elements 175, 185 are
preferably, but not necessarily, found only on first and second outer
surfaces 171b, 181b, respectively. Thus, the tissue specimen 81 being
removed is preserved for microscopic analysis and further examination.
The cables 190, 191 will cause first and second arms 170, 180 to swivel
across an approximately 90 degree arc from the open position to the closed
position. A variety of mechanisms are contemplated as within the scope of
the invention for causing the far ends 177, 187 of the first and second
arms 170, 180 to curve inwardly toward one another and toward the first
axis 159 about which the cylinder 160 rotates. One mechanism would be to
manufacture the first and second arms 170, 180 out of a material having a
memory. The memorized shape would be the inwardly curved shape of the
closed position. As the first and second arms 170, 180 extended past the
distal end of the cylinder 160, they would take on their memorized shape
and the far ends 177, 187 would bend inwardly toward one another while
rotating to cut free the dome shape at the end of the bullet-shaped
specimen of tissue 81 to be removed. The arms may be made of a variety of
materials such as stainless steel having a sufficient elastic strength, or
even a shape memory material, such as nickel titanium alloy.
Alternatively, a pair of springs (not shown) could be placed between the
inner surfaces 171a, 181a of first and second cutting arms 170, 180 and
the exterior surface 164 of cylinder 160. These springs would drive the
pivoting ends 176, 186 away from the exterior surface 164 of cylinder 160
and would simultaneously cause the far ends 177, 187 to move inwardly
toward the first axis 159 around which cylinder 160 rotates. It should be
understood that a supporting armature which prevents the first and second
cutting arms 170, 180 from returning to their memorized shape may be an
apparatus attached to the cylinder 160 or the cylinder 160 itself may act
as the supporting skeleton or framework.
The following is a description of the method of use of one embodiment of
the above-described devices for use in permitting access to tissue
surrounding a lesion in a minimally bleeding or bloodless field. The
following also describes a method of use of one embodiment of devices in
excising a specimen of tissue surrounding a lesion. Variations using other
embodiments of devices disclosed above and below and other devices known
to those of ordinary skill in the art are contemplated as within the scope
of the invention.
For example, in one method of use, the second suction ring 38 is mounted on
the movable stage 40 which has a targeting assembly (41, 42), which will
adjust to 360 degrees and variable azimuth. Once the breast 10 is fixed in
space, and the coordinates for the lesion 80 are determined, an incision
90 is made in or around the areola 12. Generally, incision 90 will be made
by the surgeon using an ordinary scalpel or other cutting means known to
those of skill in the art to preserve the skin's contour. Practicing
surgeons will understand that the incision 90 and the scar it leaves
behind are often the only visible measure a patient will have to use to
judge the quality of the surgeon's work. Thus, it is preferable if
incision 90 is made in a manner to preserve the skin's contour. It should
be understood, however, that if desired, the tissue saw 101 may be used to
create the incision 90 as well. After the incision 90 is made, the tissue
saw 101 is advanced into the breast 10 toward the lesion 80. Around the
tissue saw 101 is also advanced the retaining sleeve 103. It should be
understood in some embodiments of the device the shaft 105 will be a
hollow cylinder through which the cutting head 110 and other diagnostic
and interventional devices may be extended through and retracted as
necessary. In such cases, there may not be any need for a separate
retaining sleeve 103.
It should also be understood that a wide variety of shapes and contours for
the interior and exterior surfaces of the retaining sleeve 103 are
contemplated as within the scope of the invention. For example, the
retaining sleeve 103 may have an exterior surface 104b with a plurality of
notches in it to act as a locking mechanism for more secure fixation to
the targeting assembly (41, 42) and in particular whatever holding
mechanism the first end 45 of the first portion 41 of movable stage 40 may
have. Alternatively, it should be understood that the exterior surface
104b of retaining sleeve 103 may also be smooth and first end 45 may be a
clamp permitting infinite variation in adjusting the position of retaining
sleeve 103 with respect to the first end 45. A tissue saw 101 has an
oscillating cutting head 110 with a leading cutting surface 120, which is
preferably, but not necessarily provided with a plurality of serrations
121. The cutting head 110 has a trailing double coagulating plate (133,
135)--the tissue being first cut, and then exposed to cautery on both
faces of the slit 122. Again, it is understood that the cauterizing
element may be adjacent the cutting surface 120 or located some distance
from it. Additionally, it should be further understood, that as previously
discussed, the coagulating plate or other cauterizing element while
preferably located on cutting head 110, may instead be located on shaft
105 or retaining sleeve 103.
As the tissue saw 101 is advanced, the substantially linear slit 122 will
be enlarged to the cross-section 109 of shaft 105. The tissue saw 101 has
a cutting edge 120 which is pivoted back and forth using a driving
mechanism such as cables 140 run in the shaft 105. It should be understood
that the cutting head 110's coagulation mechanism of first cauterizing
plate 133 and second cauterizing plate 135 could be replaced with other
mechanisms known to those of ordinary skill in the art such as a laser
coagulating strip, or a series of fiber optic parts for trailing
coagulation. The tissue saw 101 enables the placement of the retaining
sleeve 103. The tissue saw 101 is then withdrawn (see FIG. 12) before the
lesion 80 is encountered and the coring head 166 is preferably advanced
(see FIG. 13) through the sleeve 103. It should be understood that
retaining sleeve 103 permits introduction of other excisional devices
and/or other diagnostic tools in a minimally bleeding or bloodless field.
In particular, it should also be understood that the coring head 166 could
instead be advanced around the exterior surface 104b of retaining sleeve
103 as opposed to through the interior of the retaining sleeve 103. This
is a less preferred embodiment, however, since the coring head 166 would
then have to be rotated in its open position (see FIG. 11A) around the
exterior surface 104b of the retaining sleeve 103 until it reached the
distal end of the retaining sleeve 103. This would be less preferred to
some extent since the coring head 166 would be inducing further trauma to
the tissue as it was rotated and sliced through the tissue that was
formerly adjacent the slit 122. However, such would not be unacceptable
since coring head 166 also includes cauterizing elements or coagulating
plates 175 and 185 on first cutting arm 170 and second cutting arm 180,
respectively. Thus, the goal of a minimally bleeding or bloodless field
would still be achieved. Additionally, the exterior surface 104b of the
retaining sleeve 103 would in this embodiment act as an armature or
supporting framework which would prevent the first cutting arm 170 and
second cutting arm 180 from moving to their closed position until the
extended past the distal end of retaining sleeve 103. This varies somewhat
from the preferred embodiment in which a supporting skeleton or framework
may be necessary at the distal end of the cylinder 160 around which the
first cutting arm 170 and second cutting arm 180 are pivoted from their
open position (see FIG. 11A) to their closed position (see FIG. 11B). It
should also be understood that in some embodiments the cylinder itself
will act as the armature supporting first cutting arm 170 and second
cutting arm 180.
The remainder of the description of the method of use will be directed to
the more preferred embodiment in which the coring head 166 is inserted
through the retaining sleeve 103 as opposed to around the exterior surface
104b of retaining sleeve 103. It should be understood, however, that the
less preferred embodiments and their variations are contemplated as within
the scope of the invention and that the variations in the method of use
between the below disclosure of the method of use for the most preferred
embodiment and that for the less preferred embodiments will be readily
apparent to those of ordinary skill in the art. At the end of the
retaining sleeve 103, the coring head 166 will encounter the tissue and
will begin to rotate. The two cutting arms 170, 180 will cut a cylinder of
tissue using the cutting surfaces 174, 184, which preferably, but not
necessarily include serrations, and as the first and second cutting arms
170, 180 are advanced and further rotated, the tissue will encounter the
single external coagulating trailing plates 175, 185.
The 90 degree arc cutting arms 170, 180 are opposite each other across the
diameter 160a of the coring head 166. As the coring head 166 is advanced
beyond the lesion 80, the cutting arms 170, 180 are rotated beyond the end
of the cylinder 160 as the cylinder 160 is no longer advanced. The arms
will cut a "dome" (see FIG. 14A) beyond the end of the lesion plug 80
producing a bullet-shaped specimen 81 (see FIG. 14B). The entire device,
along with the specimen 81, is withdrawn leaving a bullet-shaped
coagulated cavity 82 and a coagulated collapsing slit 122 (see FIG. 15).
It should be understood that the cutting arms 170, 180 may be rotated
beyond the end of the cylinder by a variety of mechanisms. These
mechanisms include such things as cables 190 and 191 attached near the
pivoting ends of the respective cutting arms, or rods attached near the
far ends of the respective arms to force them away from the distal end of
the cylinder 160. Additionally, further forces directing the cutting arms
from the open to the closed position may be generated by the use of
springs placed in between the interior surface of the pivoting end of the
cutting arms and the exterior surface of the cylinder 160.
With reference to FIG. 16, an alternative embodiment cutting head 210 is
shown with like elements labeled as previously. Cutting head 210 has upper
surface 232 and lower surface 234. In this embodiment, after the tissue
encounters cauterizing elements 233, 235, it would then encounter a series
of orifices 238 on the upper surface 232 and lower surface 234 of cutting
head 210. These orifices 238 provide an injection port for the injection
of anti-cancer agents, blood coagulation materials, and perhaps even
polymeric substances to allow for the slow and somewhat controlled release
of anti-cancer agents. The anti-cancer agents may include standard
chemotherapeutic agents such as anti-metabolites which interrupt cell
division. The anti-cancer agents may also be more specific surface
receptors known to those of ordinary skill in the art such as tamoxifen or
monoclonal antibodies. A description of one combination of blood
coagulation agent, anti-cancer agent, and polymers is found in U.S. Pat.
No. 4,536,387 to Sakamoto et al. which is hereby incorporated by
reference. Due to the extreme toxicity of some anti-cancer agents, the
application of the anti-cancer agents is thus made directly to the tissue
surrounding the area of the lesion to be excised.
With reference to FIGS. 17 and 18 there is illustrated another embodiment
of the coring device of the present invention. A coring device includes a
barrel or cylinder 260 extending along a first axis 259 about which it
rotates. The barrel 260 extends along first axis 259 between proximal end
261 (not shown) and distal end 262. The barrel 260 has an interior surface
263 and an exterior surface 264. At the distal end 262 of barrel 260 is
the coring head 266. Coring head 266 includes first, second and third
cutting arms 270, 280, 290 each having inner surfaces 271a, 281a, 291a and
outer surfaces 271b, 281b, 291b extending between near ends 276, 286, 296
and far ends 277, 287, 297, respectively. The far ends 277, 287, 297 of
each cutting arm 270, 280, 290 having cutting tips 274, 284, 294 for
severing the tissue as barrel 260 is rotated around first axis 259 and
advanced along the first axis 259 toward the targeted tissue. Trailing the
cutting tips 274, 284, 294 on the outer surface 271b, 281b, 291b of the
cutting arms 270, 280, 290 is a cauterizing element 275, 285, 295. Each of
the cutting arms 270, 280, 290 has a supporting armature 272, 282, 292
(not shown) to hold the respective cutting arms in the open position. As
the cutting tips 274, 284, 294 and the rest of the arm is extended past
the respective armature, the arms 270, 280, 290 will go from the open
position (see FIGS. 17A and 17B) to the closed position (see FIGS. 18A and
18B). It should be understood that the presence of armatures 272, 282, 292
extending from the distal end 262 of barrel 260 is just one of many
variations contemplated as within the scope of the invention. As
previously mentioned, the exterior surface 264 of barrel 260 may also act
as a supporting skeleton or framework for the respective arms, thus
obviating the need for any separate armature. It should be further
understood that the wide variety of mechanisms previously discussed for
inducing the cutting arms to curve inwardly are equally applicable in the
present embodiment.
The above described embodiments of a biopsy device are intended for use
with the previously described embodiments of a lymphostatic breast
stabilizing device, which fixes the breast in space using negative
pressure, and allows anatomical access to all parts of the breast using an
image guided targeting device. The various embodiments of the biopsy
device allow accurate removal of tissue cores from the breast; up to
several centimeters in diameter; in a bloodless field. Other advantageous
features include precise removal of cylindrical or bullet-shaped portions
of the breast by a combination of cutting strategies using a unique tissue
saw and coring device.
While the invention has been illustrated and described in detail in the
drawings and foregoing description, the same is to be considered as
illustrative and not restrictive in character, it being understood that
only the preferred embodiment has been shown and described and that all
changes and modifications that come within the spirit of the invention are
desired to be protected.
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